Effect of Vitamin D on Ovulation Rate in Women With Polycystic Ovary Syndrome

Sponsor

The University of Hong Kong (Other)

Overall Status

Recruiting

CT.gov ID

NCT04650880

Collaborator

Kwong Wah Hospital (Other), Princess Margaret Hospital, Hong Kong (Other)

220

Enrollment

Locations

Arms

47.1

Anticipated Duration (Months)

73.3

Patients Per Site

1.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a randomized double-blind controlled trial on the effect of vitamin D supplementation to assess the ovulation rate of women with polycystic ovary syndrome (PCOS) and other reproductive, endocrine and metabolic outcomes after one year of treatment.

Condition or Disease	Intervention/Treatment	Phase
Polycystic Ovary Syndrome Anovulation	Dietary Supplement: Vitamin D Other: Placebo	N/A

Detailed Description

The hypothesis is that vitamin D supplementation results in significant improvement in the ovulation rate of women with PCOS either spontaneously or with oral ovulation induction agent.

Anovulatory women with PCOS diagnosed by the Rotterdam criteria will be recruited.

Participants will be randomized to the (1) vitamin D group or (2) placebo group. Those in the vitamin D group will take vitamin D 50,000 IU/ week for 4 weeks, followed by 50,000IU once every 2 weeks for 52 weeks, whereas those in the placebo group will take placebo tablets with the same external appearance. Those who remain anovulatory after 6 months will be treated with a 6-month course of letrozole (2.5mg to 7.5mg for 5 days per cycle titrated according to response) for ovulation induction.

The primary outcome is the ovulation rate and will be compared between the 2 groups.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

220 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Treatment

Official Title:

A Randomized Double-blind Controlled Trial on the Effect of Vitamin D on Ovulation Rate of Women With Polycystic Ovary Syndrome

Actual Study Start Date :

Jan 26, 2021

Anticipated Primary Completion Date :

Dec 31, 2023

Anticipated Study Completion Date :

Dec 31, 2024

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Vitamin D Vitamin D 50,000 IU/ week for 4 weeks, followed by 50,000 IU once every 2 weeks for 52 weeks Those who remain anovulatory after 6 months will be treated with a 6-month course of letrozole (2.5mg to 7.5mg for 5 days per cycle titrated according to response) for ovulation induction.	Dietary Supplement: Vitamin D Vitamin D supplementation
Placebo Comparator: Placebo Placebo tablets with same external appearance for 52 weeks Those who remain anovulatory after 6 months will be treated with a 6-month course of letrozole (2.5mg to 7.5mg for 5 days per cycle titrated according to response) for ovulation induction.	Other: Placebo Placebo tablets with the same external appearance

Arm

Intervention/Treatment

Active Comparator: Vitamin D

Vitamin D 50,000 IU/ week for 4 weeks, followed by 50,000 IU once every 2 weeks for 52 weeks Those who remain anovulatory after 6 months will be treated with a 6-month course of letrozole (2.5mg to 7.5mg for 5 days per cycle titrated according to response) for ovulation induction.

Dietary Supplement: Vitamin D

Vitamin D supplementation

Placebo Comparator: Placebo

Placebo tablets with same external appearance for 52 weeks Those who remain anovulatory after 6 months will be treated with a 6-month course of letrozole (2.5mg to 7.5mg for 5 days per cycle titrated according to response) for ovulation induction.

Other: Placebo

Placebo tablets with the same external appearance

Outcome Measures

Primary Outcome Measures

Ovulation rate [12 months]
Serum progesterone

Secondary Outcome Measures

Change in serum 25(OH)D level [12 months]
Serum 25(OH)D
Pregnancy rate [12 months]
Positive urine or serum hCG test
Live birth rate [12 months]
Delivery of a baby after 22 completed weeks of gestational age, or with birth weight of 500 grams if the gestation age is unknown, which shows evidence of life
Change in serum anti-Mullerian hormone level [12 months]
serum AMH level
Change in antral follicle count [12 months]
Antral follicle count measured by transvaginal/ transrectal ultrasound
Androgen indices [12 months]
serum androgen and androstenedione levels, SHBG
Body mass index [12 months]
Height in cm, weight in kg, to calculate the body mass index (kg/m^2)
Change in waist and hip circumference [12 months]
waist and hip circumference in cm
Rate of diabetes mellitus/ impaired glucose intolerance [12 months]
Measured by fasting and 2 hour glucose (post 75g OGTT)
Change in systolic and diastolic blood pressure [12 months]
Blood pressure

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 40 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

Premenopausal
Aged 18-40 years
Irregular long menstrual cycles (>35 days)
PCOS according to the Rotterdam criteria
Agree for transvaginal ultrasound

Exclusion Criteria:

Use of hormonal medication (including contraception) within 3 months prior to study inclusion, except the use of a progestogen to induce withdrawal bleeding every 3 months
History of any medical condition or medications that may predispose to vitamin D sensitivity, altered vitamin D metabolism and/ or hypercalcemia, including active tuberculosis or current therapy for tuberculosis, sarcoidosis, history of renal/ ureteral stones, parathyroid disease, renal or liver failure or current use of anti-convulsants
Use of insulin-sensitizing drugs, lipid lowering drugs or anti-hypertensive
Anticipated to use the above medications in the coming one year
Known type 2 diabetes mellitus
Refusal to join the study
Abnormal blood calcium level

Contacts and Locations

Locations

	Site	City	Country
1	Kwong Wah Hospital	Hong Kong	Hong Kong
2	Princess Margaret Hospital	Hong Kong	Hong Kong
3	Queen Mary Hospital, University of Hong Kong	Hong Kong	Hong Kong

Sponsors and Collaborators

The University of Hong Kong
Kwong Wah Hospital
Princess Margaret Hospital, Hong Kong

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

The University of Hong Kong

ClinicalTrials.gov Identifier:

NCT04650880

Other Study ID Numbers:

UW20-004

First Posted:

Dec 3, 2020

Last Update Posted:

Jun 3, 2021

Last Verified:

Sep 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Polycystic Ovary Syndrome

Anovulation

Syndrome

Vitamin D

Study Results

No Results Posted as of Jun 3, 2021